000132885 001__ 132885
000132885 005__ 20240315113109.0
000132885 0247_ $$2doi$$a10.1056/NEJMoa2026983
000132885 0248_ $$2sideral$$a137758
000132885 037__ $$aART-2021-137758
000132885 041__ $$aeng
000132885 100__ $$aDeprest, Jan A.
000132885 245__ $$aRandomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia
000132885 260__ $$c2021
000132885 5060_ $$aAccess copy available to the general public$$fUnrestricted
000132885 5203_ $$aBackground
Fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease.
Methods
In this open-label trial conducted at many centers with experience in FETO and other types of prenatal surgery, we randomly assigned, in a 1:1 ratio, women carrying singleton fetuses with a moderate isolated congenital diaphragmatic hernia on the left side to FETO at 30 to 32 weeks of gestation or expectant care. Both treatments were followed by standardized postnatal care. The primary outcomes were infant survival to discharge from a neonatal intensive care unit (NICU) and survival without oxygen supplementation at 6 months of age.
Results
In an intention-to-treat analysis involving 196 women, 62 of 98 infants in the FETO group (63%) and 49 of 98 infants in the expectant care group (50%) survived to discharge (relative risk , 1.27; 95% confidence interval [CI], 0.99 to 1.63; two-sided P=0.06). At 6 months of age, 53 of 98 infants (54%) in the FETO group and 43 of 98 infants (44%) in the expectant care group were alive without oxygen supplementation (relative risk, 1.23; 95% CI, 0.93 to 1.65). The incidence of preterm, prelabor rupture of membranes was higher among women in the FETO group than among those in the expectant care group (44% vs. 12%; relative risk, 3.79; 95% CI, 2.13 to 6.91), as was the incidence of preterm birth (64% vs. 22%, respectively; relative risk, 2.86; 95% CI, 1.94 to 4.34), but FETO was not associated with any other serious maternal complications. There were two spontaneous fetal deaths (one in each group) without obvious cause and one neonatal death that was associated with balloon removal.
Conclusions
This trial involving fetuses with moderate congenital diaphragmatic hernia on the left side did not show a significant benefit of FETO performed at 30 to 32 weeks of gestation over expectant care with respect to survival to discharge or the need for oxygen supplementation at 6 months. FETO increased the risks of preterm, prelabor rupture of membranes and preterm birth. (Funded by the European Commission and others; TOTAL ClinicalTrials.gov number, NCT00763737. opens in new tab.)
000132885 536__ $$9info:eu-repo/grantAgreement/EC/FP6/37409/EU/Soft tissue engineering for congenital birth defects in children: new treatment modalities for spina bifida, urogenital and abdominal wall defects/EUROSTEC
000132885 540__ $$9info:eu-repo/semantics/openAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/
000132885 590__ $$a176.082$$b2021
000132885 591__ $$aMEDICINE, GENERAL & INTERNAL$$b2 / 172 = 0.012$$c2021$$dQ1$$eT1
000132885 592__ $$a24.907$$b2021
000132885 593__ $$aMedicine (miscellaneous)$$c2021$$dQ1
000132885 594__ $$a110.5$$b2021
000132885 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000132885 700__ $$aBenachi, Alexandra
000132885 700__ $$aGratacos, Eduard
000132885 700__ $$aNicolaides, Kypros H.
000132885 700__ $$aBerg, Christoph
000132885 700__ $$aPersico, Nicola
000132885 700__ $$aBelfort, Michael
000132885 700__ $$aGardener, Glenn J.
000132885 700__ $$aVille, Yves
000132885 700__ $$aJohnson, Anthony
000132885 700__ $$aMorini, Francesco
000132885 700__ $$aWielgos, Miroslaw
000132885 700__ $$aVan Calster, Ben
000132885 700__ $$aDeKoninck, Philip L.J.
000132885 700__ $$afor the TOTAL Trial for Moderate Hypoplasia Investigators
000132885 700__ $$0(orcid)0000-0003-4720-8231$$aTajada Duaso, Mauricio$$uUniversidad de Zaragoza
000132885 7102_ $$11013$$2645$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Obstetricia y Ginecología
000132885 773__ $$g385, 2 (2021), 119-129$$pN. Engl. j. med.$$tNEW ENGLAND JOURNAL OF MEDICINE$$x0028-4793
000132885 8564_ $$s1225986$$uhttps://zaguan.unizar.es/record/132885/files/texto_completo.pdf$$yVersión publicada
000132885 8564_ $$s2705369$$uhttps://zaguan.unizar.es/record/132885/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000132885 909CO $$ooai:zaguan.unizar.es:132885$$particulos$$pdriver
000132885 951__ $$a2024-03-15-08:52:02
000132885 980__ $$aARTICLE